Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Recruiting now · Not applicable

Conditions studied: Refractory Chronic Cough, Unexplained Chronic Cough, Cough Hypersensitivity

In brief

The goal of this single-cohort clinical trial is to learn whether a smartphone-based Cough Management (CM) program can reduce cough frequency and burden in adults (21-80 years) who have refractory or unexplained chronic cough. The main questions it aims to answer are: * Does four weeks of using the CM feature in the CoughPro app lower objective cough rate (coughs per hour) compared with each participant's one-week baseline? * Does the program also lessen cough intensity (bout metrics) and improve patient-reported quality-of-life scores on the Leicester Cough Questionnaire and PGI-S? Participants will: * Wear a Hyfe CoughMonitor smartwatch continuously for 6 weeks (1-week baseline, 4-week intervention, 1-week follow-up), charging it nightly. * Complete science-based in-app CM lessons based on behavioral cough-suppression therapy and practice the techniques during the 4-week intervention. * Fill out online questionnaires (LCQ and PGI-S) at baseline and at the end of Week 4. * Join a brief exit interview, then return the smartwatch and receive a compensation voucher.

Key facts

Study ID: NCT07070895
Run by: Hyfe Inc
People needed: 20
Starts: 2025-03-27
Expected to finish: 2025-09-01
Last updated by the study team: 2025-09-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 21 or older.
Currently suffering from a cough that started at least 8 weeks ago that is largely unproductive (i.e., at least 50% of the time the cough produces zero mucus that needs to be spit out or swallowed).
Normal chest X-ray or chest CT scan at some point that was prescribed specifically for their cough.
At least one physician visit for cough with standard-of-care therapy but inadequate symptom relief.
Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur.
Ability to comply: willing/able to wear the watch daily for the required duration of study and to complete all required questionnaires.
Informed consent: understanding of the study procedures and agreement to comply with protocol.

You may not qualify if…

Recent upper respiratory infection (past 4 weeks).
History of hemoptysis (coughing up blood) since onset of the current cough.
Current smoker (incl. vaping) of any substance.
≥10 consecutive pack-years smoking history within <10 years prior to screening.
Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.
Current or past head/neck cancer.
Difficulty swallowing.
On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
Prior treatment for cough by a speech-language pathologist.
Living with another individual with a frequent cough that would interfere with monitoring.
Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.
Major scheduled surgery during the study period.

Where it is running

Hyfe Inc. — Wilmington, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

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